ModifiedCignaPolicy N/A

Vesicular Monoamine Transporter Type 2 Inhibitors Drug Quantity Management Policy - Per Rx

Cigna's drug quantity management policy governing per-prescription maximum quantities for vesicular monoamine transporter type 2 (VMAT2) inhibitors (deutetrabenazine, valbenazine, tetrabenazine) for covered health benefit plans administered by Cigna companies.

Policy Summary

PayerCigna

PolicyVesicular Monoamine Transporter Type 2 Inhibitors Drug Quantity Management Policy - Per Rx

Policy CodePolicy N/A

Change TypeQuantity limits added and revised for Austedo XRIngrezza Sprinkle limits and one-time override added

Effective DateN/A

Next Review DateN/A

Key ActionSubmit documentation of pharmacogenetic status or clinical rationale to request quantity overrides (e.g., CYP2D6 status or rationale for increasing Ingrezza from 40 mg to 80 mg).

SourceLink

POLICY UPDATE CHANGES

Added existing quantity limits for Austedo XR to policy.

Changed quantity limits for several Austedo XR strengths (e.g., 6 mg from 210 to 90 tablets retail; other strengths adjusted to 30 retail / 90 home delivery).

Added quantity limits for Ingrezza Sprinkle formulations (30 retail / 90 home delivery) and a one-time override when increasing from 40 mg to 80 mg daily.

1 yearauthorization duration

60Austedo 6 mg retail max/Rx

180Austedo 6 mg home delivery max/Rx

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30Ingrezza retail max/Rx

90Ingrezza home delivery max/Rx

240/720Tetrabenazine possible max (if CYP2D6 ext/int)

Coverage Criteria

Drug Quantity Limits

Coverage is subject to per-prescription maximum quantities by product and strength; if the Drug Quantity Management rule is not met, coverage is determined by the criteria and prior authorization.

Per-prescription limits: Prescriptions exceeding the specified Retail or Home Delivery maximum quantity per Rx for the listed product/strength will require review/authorization.see product-specific limits

Approvals provided for 1 year unless noted

Quantity limit overrides

Overrides to the standard quantity limits are covered as medically necessary when ALL of the following drug-specific criteria are met (per itemized rules):

Tetrabenazine 12.5 mg: If the patient is an extensive or intermediate metabolizer of CYP2D6 AND needs a dose greater than 50 mg/day, approve the quantity requested not to exceed 240 tablets per dispensing at retail and not to exceed 720 tablets per dispensing at home delivery.>50 mg/day

supports larger dispensing for selected metabolizer status

Tetrabenazine 25 mg: If the patient is an extensive or intermediate metabolizer of CYP2D6 AND needs a dose greater than 50 mg/day, approve the quantity requested not to exceed 120 tablets per dispensing at retail and not to exceed 360 tablets per dispensing at home delivery.>50 mg/day

strength-specific limits

Ingrezza 40 mg initiation to 80 mg increase: If the patient is initiating therapy and is increasing the daily dose from 40 mg to 80 mg daily, approve a one-time override for the requested quantity not to exceed 60 capsules at retail and home delivery.one-time

only for initiation dose escalation

Any exception to the quantity limits not described in the specified drug/strength criteria is considered not medically necessary.

Requests that exceed the listed per‑prescription quantity limits without meeting one of the outlined, drug‑specific exception criteria are considered not medically necessary and will be denied.

Provider Actions and Documentation

Prior Authorization

Per-prescription quantity limits and authorization duration

Per-prescription quantity limits are enforced as listed in the Drug Quantity Limits table. All approvals are provided for 1 year in duration unless otherwise noted. One-time overrides (when allowed) are provided for 1 year in duration.

Enforcement is per prescription (per Rx) and applies to retail and home delivery maximums as specified for each product/strength.
Approvals are typically granted for a 12-month period; one-time overrides are also granted for 12 months.

Denial Risk

Per-Rx quantity limits and exception requirement

Exceptions to the per-Rx quantity limits are allowed only when the specific exception criteria for the drug and strength are met (see Criteria). Requests that do not meet the stated exception criteria are considered not medically necessary.

Only the documented exceptions listed under the Criteria section (e.g., pharmacogenetic metabolizer status, documented dose escalation rationale) qualify for overrides.

Definitions

inv-14: Vesicular monoamine transporter type 2 inhibitors — list of agents

DefinitionVesicular monoamine transporter type 2 (VMAT2) inhibitors — Austedo (deutetrabenazine) / Austedo XR (deutetrabenazine extended‑release) / Ingrezza (valbenazine) / Ingrezza Sprinkle (valbenazine) / Xenazine (tetrabenazine, generic)

Included agentsAustedo (deutetrabenazine) — immediate‑release tablets

Included agentsAustedo XR (deutetrabenazine) — extended‑release tablets and titration kits

Included agentsIngrezza (valbenazine) — capsules, including initiation blister pack and Sprinkle formulation

Included agentsXenazine (tetrabenazine, generic) — tablets (12.5 mg and 25 mg)

inv-15: CYP2D6 extensive or intermediate metabolizer — definition and relevance to dosing/limits

Initial Therapy Criteria

Label dosing and titration

Dosing and titration summaries from product labeling.

Austedo/Austedo XR starting dose: Start 12 mg/day (6 mg BID for Austedo or 12 mg QD for Austedo XR); titrate weekly by 6 mg/day up to 48 mg/day. For CYP2D6 poor metabolizers or patients receiving strong CYP2D6 inhibitors, limit total daily dose to 36 mg. When switching from tetrabenazine, use a starting dose based on prior tetrabenazine dose; when switching between Austedo and Austedo XR, use the same total daily dose.max 48 mg/day (36 mg/day if poor CYP2D6 metabolizer or strong CYP2D6 inhibitor)

Dose increases at weekly intervals by 6 mg/day

Ingrezza starting dose: Start 40 mg QD for tardive dyskinesia or chorea; may increase by 20 mg every 2 weeks up to 80 mg QD (or increase after 1 week for some regimens). Reduce to 40 mg QD for moderate/severe hepatic impairment, CYP2D6 poor metabolizers, or when receiving CYP3A4 inhibitors/strong CYP2D6 inhibitors.40-80 mg QD

Dose adjustments depend on indication and interacting medications

Step Therapy

When Drug Quantity Management rule not met	Action
If the Drug Quantity Management rule is not met for the requested medication at point of service	Coverage will be determined by the Criteria below; prior authorization/coverage review may be required. Approvals are provided for 1 year unless otherwise noted.
Note	One‑time overrides, when specified in the criteria, are provided for 1 year in duration.

Drug(s)	Override recommendation
Austedo (deutetrabenazine) and Austedo XR (all strengths, including titration packs)	No overrides recommended.

Per-Rx Quantity Limits by Product and Strength

inv-19: Austedo 6 mg tablets — retail max per Rx (units)

Product/strengthAustedo 6 mg tablets

Retail maximum per Rx (units)60 tablets

Unit typetablets per prescription (Retail)

inv-20: Austedo 6 mg tablets (Home Delivery) — home delivery max per Rx (units)

Product/strengthAustedo 6 mg tablets (Home Delivery)

Home delivery maximum per Rx (units)180 tablets

Unit typetablets per prescription (Home Delivery)

Background

Vesicular monoamine transporter type 2 (VMAT2) inhibitors — including deutetrabenazine (Austedo/Austedo XR), valbenazine (Ingrezza/Ingrezza Sprinkle), and tetrabenazine (Xenazine and generics) — are oral agents used to treat movement disorders such as chorea associated with Huntington’s disease and, for some agents, tardive dyskinesia. Dosing, titration, and maximum recommended daily doses vary by agent and are influenced by patient factors such as CYP2D6 metabolizer status and concomitant use of CYP inhibitors, which can affect allowable dispensing quantities and override criteria.

Policy Summary

PayerCigna

PolicyVesicular Monoamine Transporter Type 2 Inhibitors Drug Quantity Management Policy - Per Rx

Policy CodePolicy N/A

Change TypeQuantity limits added and revised for Austedo XRIngrezza Sprinkle limits and one-time override added

Effective DateN/A

Next Review DateN/A

Key ActionSubmit documentation of pharmacogenetic status or clinical rationale to request quantity overrides (e.g., CYP2D6 status or rationale for increasing Ingrezza from 40 mg to 80 mg).

SourceLink

On This Page

Any other requested exception beyond the listed criteria will be denied as not medically necessary.

Denial Risk

Quantity limit exceedance

If a request exceeds the published quantity limits and does not meet a specified exception criterion, the request should be considered not medically necessary and may be denied.

Requests exceeding limits without meeting exception criteria are non-covered.
When limits are exceeded at point of service, coverage will be determined by the Criteria below and a prior authorization may be required.

Documentation Required

Required documentation and billing

Coverage determinations require review of the applicable benefit documents, any relevant laws/regulations, and collateral materials. Claims must be billed using the most appropriate codes as of the date of submission.

Provide the applicable benefit plan document and any state/federal mandates when requesting coverage determinations.
Use appropriate diagnosis and procedure/drug codes; claims without covered codes under the policy will be denied as not covered.

Documentation Required

Supporting documentation for overrides

Supporting documentation is required for overrides that allow dose escalation beyond quantity limits. Acceptable documentation includes pharmacogenetic testing results or a clear clinical rationale.

For tetrabenazine (Xenazine) higher-dose approvals, documentation that the patient is an extensive or intermediate CYP2D6 metabolizer is required to approve larger quantities.
For Ingrezza dose escalation from 40 mg to 80 mg, provide documentation supporting initiation and dose increase to allow the one-time override quantity.

Note

Austedo override stance

Austedo and Austedo XR (all strengths, including titration packs): no overrides recommended.

Do not request overrides for Austedo or Austedo XR; requests for exceptions are not recommended per policy.

DefinitionCYP2D6 extensive or intermediate metabolizer — a patient pharmacogenetic status indicating normal (extensive) or intermediate CYP2D6 enzyme activity

RelevanceIf a patient is an extensive or intermediate CYP2D6 metabolizer and requires tetrabenazine at doses >50 mg/day, larger per‑dispensing quantities are allowed per policy exceptions

Policy implicationDocumentation of metabolizer status (e.g., pharmacogenetic testing) is required to approve quantity overrides for tetrabenazine

Affected productsXenazine (tetrabenazine) 12.5 mg and 25 mg tablets — strength‑specific exception limits apply when metabolizer status and dosing criteria are met

Tetrabenazine starting dose: Start 12.5 mg QD, increase after 1 week to 25 mg/day and up-titrate weekly by 12.5 mg/day; if 37.5–50 mg/day needed, use a TID regimen. Patients requiring >50 mg/day should be genotyped for CYP2D6; extensive/intermediate metabolizers may titrate up to a maximum of 100 mg/day (max single dose 37.5 mg), while poor metabolizers have lower maximums (total not to exceed 50 mg/day when on strong CYP2D6 inhibitors).max daily 100 mg for extensive metabolizers; lower limits for poor metabolizers or with strong CYP2D6 inhibitors

Genotype CYP2D6 if dose >50 mg/day; dosing influenced by metabolizer status and interacting drugs

inv-21: Austedo 9 mg tablets (Retail) — retail max per Rx

Product/strengthAustedo 9 mg tablets (Retail)

Retail maximum per Rx (units)120 tablets

Unit typetablets per prescription (Retail)

inv-22: Austedo 9 mg tablets (Home Delivery) — home delivery max per Rx

Product/strengthAustedo 9 mg tablets (Home Delivery)

Home delivery maximum per Rx (units)360 tablets

Unit typetablets per prescription (Home Delivery)

inv-23: Austedo 12 mg tablets (Retail) — retail max per Rx

Product/strengthAustedo 12 mg tablets (Retail)

Retail maximum per Rx (units)120 tablets

Unit typetablets per prescription (Retail)

inv-24: Austedo 12 mg tablets (Home Delivery) — home delivery max per Rx

Product/strengthAustedo 12 mg tablets (Home Delivery)

Home delivery maximum per Rx (units)360 tablets

Unit typetablets per prescription (Home Delivery)

inv-25: Austedo XR (all listed strengths) — retail max per Rx (common standardized amount)

Product/strengthAustedo XR (all listed strengths)

Retail maximum per Rx (common standardized amount)30 tablets

Unit typeextended‑release tablets per prescription (Retail)

inv-26: Austedo XR (all listed strengths) — home delivery max per Rx (common standardized amount)

Product/strengthAustedo XR (all listed strengths)

Home delivery maximum per Rx (common standardized amount)90 tablets

Unit typeextended‑release tablets per prescription (Home Delivery)

inv-27: Austedo XR Titration Kit (6-12-24 mg) [42 tablets total] — kit quantity per Rx

Product/kitAustedo XR Titration Kit (6-12-24 mg) [42 tablets total]

Kit quantity per Rx42 tablets (1 kit)

Unit typetablets (titration kit) per prescription

inv-28: Austedo XR Titration Kit (12-18-24-30 mg) [28 tablets total] — kit quantity per Rx

Product/kitAustedo XR Titration Kit (12-18-24-30 mg) [28 tablets total]

Kit quantity per Rx28 tablets (1 kit)

Unit typetablets (titration kit) per prescription

inv-29: Ingrezza (valbenazine) 40 mg, 60 mg, 80 mg capsules (Retail) — retail max per Rx

Product/strengthIngrezza (valbenazine) 40 mg, 60 mg, 80 mg capsules (Retail)

Retail maximum per Rx (units)30 capsules

Unit typecapsules per prescription (Retail)

inv-30: Ingrezza (valbenazine) 40 mg, 60 mg, 80 mg capsules (Home Delivery) — home delivery max per Rx

Product/strengthIngrezza (valbenazine) 40 mg, 60 mg, 80 mg capsules (Home Delivery)

Home delivery maximum per Rx (units)90 capsules

Unit typecapsules per prescription (Home Delivery)

inv-31: Ingrezza initiation blister pack (7 x 40 mg + 21 x 80 mg) (Retail) — initiation pack retail quantity

ProductIngrezza initiation blister pack (7 x 40 mg + 21 x 80 mg) (Retail)

Initiation pack retail quantity28 capsules (1 pack)

Unit typecapsules per initiation pack (Retail)

inv-32: Austedo XR 36 mg, 42 mg, 48 mg extended-release tablets — retail/home delivery per-Rx limits

Product/strengthAustedo XR 36 mg, 42 mg, 48 mg extended‑release tablets

Retail/Home delivery per‑Rx limitsRetail 30 tablets per Rx; Home delivery 90 tablets per Rx

Unit typeextended‑release tablets per prescription

inv-33: Austedo XR titration kits (6-12-24 mg [42 tablets], 12-18-24-30 mg [28 tablets]) — kit limits retail/home delivery

Product/kitAustedo XR titration kits (6‑12‑24 mg [42 tablets], 12‑18‑24‑30 mg [28 tablets])

Retail/Home delivery kit limitsRetail 42 or 28 tablets (1 kit) per Rx as applicable; Home delivery same

Unit typetablets (titration kit) per prescription

inv-34: Austedo XR other strengths (6 mg, 12 mg, 18 mg, 24 mg, 30 mg listed historically) — standardized retail/home delivery limits and adjustments

Product/strength groupAustedo XR other strengths (6 mg, 12 mg, 18 mg, 24 mg, 30 mg listed historically)

Standardized limitsGenerally Retail 30 tablets per Rx; Home delivery 90 tablets per Rx (applies to newly added strengths and adjusted items)

NotesPolicy history documents adjustments to several Austedo XR strengths and standardization of limits

inv-35: Ingrezza and Ingrezza Sprinkle (40 mg, 60 mg, 80 mg) — retail/home delivery/initiation pack limits

ProductsIngrezza and Ingrezza Sprinkle (40 mg, 60 mg, 80 mg)

Retail/Home delivery limitsRetail 30 capsules per Rx; Home delivery 90 capsules per Rx

Initiation packInitiation blister pack retail 28 capsules; Home delivery initiation pack 28 capsules

inv-36: Xenazine (tetrabenazine) 12.5 mg tablets — retail/home delivery limits with possible exceptions

Product/strengthXenazine (tetrabenazine) 12.5 mg tablets

Standard limitsRetail 120 tablets per Rx; Home delivery 360 tablets per Rx

ExceptionIf patient is CYP2D6 extensive or intermediate metabolizer AND needs >50 mg/day, may approve up to 240 tablets (retail) / 720 tablets (home delivery)

inv-37: Xenazine (tetrabenazine) 25 mg tablets — retail/home delivery limits with possible CYP2D6-related exceptions

Product/strengthXenazine (tetrabenazine) 25 mg tablets

Standard limitsRetail 60 tablets per Rx; Home delivery 180 tablets per Rx

ExceptionIf patient is CYP2D6 extensive or intermediate metabolizer AND needs >50 mg/day, may approve up to 120 tablets (retail) / 360 tablets (home delivery)